Cleared Traditional

K895396 - CYBERFLUOR FIAGEN TSH

K895396 is the FDA 510(k) clearance for CYBERFLUOR FIAGEN TSH by Cyberfluor, Inc.. It is a Class 2 Toxicology device (product code JLW) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K895396 · Cyberfluor, Inc. · Toxicology device
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Oct 1989
Decision
60d
Days
Class 2
Risk

K895396 is an FDA 510(k) clearance for the CYBERFLUOR FIAGEN TSH. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on October 31, 1989 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1690 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cyberfluor, Inc. devices

Submission Details

510(k) Number K895396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1989
Decision Date October 31, 1989
Days to Decision 60 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 87d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 144
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K895396.
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K890802 · Bio-Rad · Mar 1989
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K885157 · Ventrex Laboratories, Inc. · Feb 1989